Safety alerts
21 safety alerts appeared in South Korea during Week 16, 2026. Safety concentration usually matters to quality, vigilance, and post-market surveillance teams because it can reveal emerging field risks.
South Korea medical device regulatory intelligence, Week 16, 2026.
Signals from 2026-04-13 to 2026-04-19, covering safety alerts, regulatory changes, device registrations, market movement, and source activity for South Korea.
Signals
21
Sources
1
Index status
Indexable
EXECUTIVE SUMMARY
South Korea generated 21 qualifying medical device signals during Week 16, 2026. Safety alerts led the week with 21 signals, while FDA Device Enforcement was the most active source. Philips recalls ALLURA Xper FD20 OR Table due to intermittent X-ray imaging issues with the foot switch. Medtronic MiniMed's Paradigm Insulin Pumps are recalled due to risks of insulin over- and under-delivery affecting patient safety.
Key observations
Safety alerts accounted for 21 of 21 qualifying signals, making it the main review lane for the week.
The remaining signals were spread across smaller categories, suggesting a lower-concentration week.
FDA Device Enforcement contributed 21 signals, so source-level follow-up should start there.
Enforcement appeared repeatedly in the highlighted signals, which may warrant closer product, manufacturer, or competitor tracking.
Category interpretation
Recommended monitoring focus
- Review MFDS safety and recall activity for product categories that overlap your portfolio.
- Maintain weekly monitoring for South Korea, especially when low-volume weeks precede regulator database updates.
- Validate high-impact items against the original source before using them in quality or regulatory decision-making.
- Compare this week with the next completed week to separate one-off noise from sustained category movement.
Source-backed signal evidence
These source-linked items support the weekly analysis above. They are included for verification and follow-up, not as a raw feed export.
FDA Device Enforcement·Safety alerts·
Enforcement Class II: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Philips recalls ALLURA Xper FD20 OR Table due to intermittent X-ray imaging issues with the foot switch.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Paradigm Insulin Pump (MMT-712, MMT-715) (Medtronic MiniMed, Inc.)
Medtronic MiniMed's Paradigm Insulin Pumps are recalled due to risks of insulin over- and under-delivery affecting patient safety.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Azurion 5 M12; System Code: (1)722227, (2)722231; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Philips recalled Azurion 5 M12 due to intermittent X-ray imaging issues with the wired foot switch.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; (Siemens Healthcare Diagnostics, Inc.)
Siemens recalls Atellica CH A1c_E due to potential negative bias affecting diabetes diagnosis.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: MiniMed 620G Insulin Pump (MMT-1750) (Medtronic MiniMed, Inc.)
Medtronic's MiniMed 620G insulin pump recalled due to risks of insulin over- and under-delivery affecting patient safety.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) (Medtronic MiniMed, Inc.)
Medtronic's Paradigm REAL-Time Veo Insulin Pump recalled due to insulin delivery errors causing severe health risks.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) (Medtronic MiniMed, Inc.)
Medtronic MiniMed's Paradigm REAL-Time Insulin Pumps are recalled due to insulin delivery issues causing severe health risks.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: E (Intuitive Surgical, Inc.)
Intuitive Surgical recalls da Vinci S, Si Cautery Hook due to frayed cables, affecting global distribution.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) (Medtronic MiniMed, Inc.)
Medtronic's MiniMed 720G insulin pumps recalled due to risks of insulin over- and under-delivery affecting patient safety.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: SIGNA Premier systems (GE Healthcare LLC)
GE Healthcare recalls SIGNA Premier systems due to potential injury from ferrous fittings in MR scanners.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist (Intuitive Surgical, Inc.)
The da Vinci S, Si Grasping Retractor Instrument is recalled due to complaints of broken grip cables.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: ALLURA Xper FD10F; System Code: 722002; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Philips recalled ALLURA Xper FD10F due to intermittent X-ray imaging issues with the wired foot switch.
SourceSafety alerts
FDA Device Enforcement·Safety alerts·
Enforcement Class II: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Philips recalls ALLURA Xper FD20 OR Table due to intermittent X-ray imaging issues with the foot switch.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Paradigm Insulin Pump (MMT-712, MMT-715) (Medtronic MiniMed, Inc.)
Medtronic MiniMed's Paradigm Insulin Pumps are recalled due to risks of insulin over- and under-delivery affecting patient safety.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Azurion 5 M12; System Code: (1)722227, (2)722231; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Philips recalled Azurion 5 M12 due to intermittent X-ray imaging issues with the wired foot switch.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; (Siemens Healthcare Diagnostics, Inc.)
Siemens recalls Atellica CH A1c_E due to potential negative bias affecting diabetes diagnosis.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: MiniMed 620G Insulin Pump (MMT-1750) (Medtronic MiniMed, Inc.)
Medtronic's MiniMed 620G insulin pump recalled due to risks of insulin over- and under-delivery affecting patient safety.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) (Medtronic MiniMed, Inc.)
Medtronic's Paradigm REAL-Time Veo Insulin Pump recalled due to insulin delivery errors causing severe health risks.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) (Medtronic MiniMed, Inc.)
Medtronic MiniMed's Paradigm REAL-Time Insulin Pumps are recalled due to insulin delivery issues causing severe health risks.
SourceFDA Device Enforcement·Safety alerts·
Enforcement Class II: Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: E (Intuitive Surgical, Inc.)
Intuitive Surgical recalls da Vinci S, Si Cautery Hook due to frayed cables, affecting global distribution.
SourceTrack these signals continuously.
MedFlux monitors regulators and medical device market sources across priority countries so regulatory, quality, and strategy teams can review changes without manually checking agency databases.